Alzheimer Disease, Dementia, Dementia, Mixed, Dementia, Vascular
Conditions
Keywords
psychosocial, non-pharmacological
Brief summary
This study will involve testing of an Alpha version of an app called Building Relationships using Artificial Intelligence and Nostalgia or BRAIN. The BRAIN App will be the first -ever artificial intelligence infused CST app for PWD. The app has two main goals: (1) to foster positive relationships between the care triad, and (2) to promote QoL while reducing responsive behaviors in PWD. Testing will examine the app's impact on engagement/affect for both PWD and professional Care Partners.
Detailed description
A quasi-experimental pretest / posttest design will be used. During a four-week baseline period, researchers will collect data on engagement, quality of life, neuropsychiatric symptoms, and quality of the care-patient relationship. Participants will then use the BRAIN app for four weeks, during which engagement data will be collect. After the intervention period, researchers will collect data again on quality of life, neuropsychiatric symptoms, and quality of the carer-patient relationship.
Interventions
BEHAVIORALThe BRAIN App
The BRAIN App will be the first-ever artificial intelligence enabled cognitive stimulation therapy app, specifically designed for PWD. The goal of the app is to foster positive relationships between the care triad.
Sponsors
Hopeful Aging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PWD Inclusion Criteria: * diagnosed with dementia (any type) * resident in ALF or NH * 65+ years old * read and speak English * exhibit at least one responsive behavior on the NPI-NH or score below maximum score on the DEMQOL PWD
Exclusion criteria
* bed-confined * completely unable to communicate verbally * have serious visual or hearing impairments * show signs of rapid decline or over the last six months Staff and Family Member Inclusion Criteria * 18+ years old * speak and read English Staff and Family Member
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS) | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | The Negative Items Sub-score on the EPWDS is the total score for the five following items: (1) Displays negative affect, (2) Appears inattentive, has an unfocused stare or turns head/eyes away from the activity, materials used, or the person/s involved, (3) Refuses to participate in the activity or in a conversation related to the activity by verbalizing e.g. no, stop, etc. OR verbalizes negative comment, complaint, and sound in response to or related to the activity, or the materials used, or the person/s involved, and (4) In response to the activity, is distracting or disrupting others (e.g., Staff/facilitator and other residents). During baseline, multiple observations of standard activities were observed and a mean was calculated for the negative item sub-score. Then, again, during treatment, multiple observations were taken and mean was calculate. Total score ranges from 0 to 16. Lower scores represent a better outcome. |
| Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome. |
| Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. |
| Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. |
| Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. |
| Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome. |
| Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS) | Baseline (Weeks 1-4) and Treatment (Weeks 5-10) | The Positive Items Sub-score on the EPWDS is the total score for the five following items: (1) Displays positive affect, (2) maintains eye contact, (3) Initiates, participates, or maintains verbal conversation, sounds or gestures (e.g., nodding) in response to the activity, or the materials used, or the person/s involved, (4) Responds to an activity by approaching, reaching out, touching, holding or handling the activity, the material used, or the person/s involved, and (5) Uses the activity or the material/s to encourage others to interact, or as a communication channel to interact and talk with others (e.g., staff and other residents). During baseline, multiple observations of standard activities were observed and a mean was calculated for the positive item sub-score. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value is 0 and the maximum score is 20. Higher scores represent a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS) | Baseline (Weeks 1-4) and Post-Treatment (Week 11) | The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symtoms. The score ranges from 0 to 120. Lower scores represent a better outcome. |
| Change From Pre-Test to Post-Test for the Knowledge Assessment for BRAIN Training for Staff | Baseline (Week 1) and Post-Training (Week 5) | Staff took a quiz at pre-test and again at post-test. Scores range from 0 to 100, with higher scores representing a better outcome |
| Percent of Staff Who Thought Residents Enjoyed BRAIN Activities | Post-Treatment (Week 11) | Staff were asked if they thought residents enjoyed using the BRAIN Activities. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome. |
| Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues | Post-Treatment (Week 11) | Staff were asked if they would recommend BRAIN Activities to colleagues. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome. |
| Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia. | Post-Treatment (Week 11) | Staff were asked if they thought the BRAIN app would improve quality of life of persons with dementia.. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome. |
| Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL) | Baseline (Weeks 1-4) and Post-Treatment (Week 11) | The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Persons With Dementia Persons with dementia (PWD) were the primary or target participants in the study. PWD participated by initially participating in baseline interviews. Then, the person was invited to participate in the BRAIN intervention twice per week for five weeks. | 22 |
| Staff Members Staff members participated by providing feedback on the app and training. In addition, staff took pre- and post-quizzes for the training. | 13 |
| Family Members Family members exclusively participated by providing information about their loved one's (i.e., person with dementia's) background, interests and preferences. As such, there is no outcome data for family members. Please note: although we originally expected one family some persons with dementia did not have a family member available who could be contacted regarding their background, interests, and preferences. As such, the total number of family members is not equal to the persons with dementia. When a family member want not available, information about the person with dementia was obtained by the person with dementia himself or herself. | 10 |
| Total | 45 |
Baseline characteristics
| Characteristic | Persons With Dementia | Staff Members | Family Members | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 0 Participants | 4 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 13 Participants | 6 Participants | 19 Participants |
| Age, Continuous | 83.73 years STANDARD_DEVIATION 6.53 | 45.92 years STANDARD_DEVIATION 11.67 | 65.00 years STANDARD_DEVIATION 11.1 | 68.6 years STANDARD_DEVIATION 18.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 12 Participants | 10 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 10 Participants | 10 Participants | 36 Participants |
| Region of Enrollment United States | 22 participants | 13 participants | 10 participants | 45 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 6 Participants | 33 Participants |
| Sex: Female, Male Male | 8 Participants | 0 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 22 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 22 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale
Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale | .72 score on scale | Standard Deviation 0.48 |
Comparison: Using a paired sample t-test (two tailed), we wished to examine whether there was an increase in Constructive Engagement and Pleasure and a reduction in Passive Engagement, Distracted Engagement, and Non-Engagement, from baseline to treatment. With an anticipated PWD sample of 24, and using means and standard deviations from the PI's previous studies, we calculated a power of 90% to detect effects (alpha = .05; one-tailed test). (3) PWD and staff report high satisfaction wip-value: <0.0195% CI: [0.51, 0.94]t-test, 2 sided
Primary
Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
The Negative Items Sub-score on the EPWDS is the total score for the five following items: (1) Displays negative affect, (2) Appears inattentive, has an unfocused stare or turns head/eyes away from the activity, materials used, or the person/s involved, (3) Refuses to participate in the activity or in a conversation related to the activity by verbalizing e.g. no, stop, etc. OR verbalizes negative comment, complaint, and sound in response to or related to the activity, or the materials used, or the person/s involved, and (4) In response to the activity, is distracting or disrupting others (e.g., Staff/facilitator and other residents). During baseline, multiple observations of standard activities were observed and a mean was calculated for the negative item sub-score. Then, again, during treatment, multiple observations were taken and mean was calculate. Total score ranges from 0 to 16. Lower scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Negative Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS) | -1.07 score on scale | Standard Deviation 1.1 |
p-value: <0.00195% CI: [-1.55, -0.58]t-test, 2 sided
Primary
Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale
Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Non-Engagement on the Menorah Park Engagement Scale | -0.15 score on scale | Standard Deviation 0.34 |
p-value: 0.05395% CI: [-0.3, 0]t-test, 2 sided
Primary
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale | -.25 score on scale | Standard Deviation 0.4 |
p-value: 0.00895% CI: [-0.43, -0.07]t-test, 2 sided
Primary
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale | -0.33 score on scale | Standard Deviation 0.6 |
p-value: 0.01795% CI: [-0.59, -0.07]t-test, 2 sided
Primary
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of standard activities were observed and a mean was calculated. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale | .66 score on scale | Standard Deviation 0.28 |
p-value: <0.0195% CI: [0.54, 0.79]t-test, 2 sided
Primary
Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS)
The Positive Items Sub-score on the EPWDS is the total score for the five following items: (1) Displays positive affect, (2) maintains eye contact, (3) Initiates, participates, or maintains verbal conversation, sounds or gestures (e.g., nodding) in response to the activity, or the materials used, or the person/s involved, (4) Responds to an activity by approaching, reaching out, touching, holding or handling the activity, the material used, or the person/s involved, and (5) Uses the activity or the material/s to encourage others to interact, or as a communication channel to interact and talk with others (e.g., staff and other residents). During baseline, multiple observations of standard activities were observed and a mean was calculated for the positive item sub-score. Then, again, during treatment, multiple BRAIN activities were observed and a mean was calculated. The minimum value is 0 and the maximum score is 20. Higher scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment for Positive Items Sub-score on the Engagement of Persons With Dementia Scale (EPWDS) | 4.11 score on scale | Standard Deviation 3.35 |
p-value: <0.00195% CI: [2.62, 5.6]t-test, 2 sided
Secondary
Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)
The Dementia Related Quality of Life Scale is a 28 item scale that examines quality of life in persons with dementia. The score ranges for 28 to 112. Higher scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL) | 6.02 score on scale | Standard Deviation 11.4 |
p-value: 0.02295% CI: [0.97, 11.1]t-test, 2 sided
Secondary
Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)
The NPI-NH examines 10 types of neuropsychiatric symptoms in persons with dementia, with the FxS score looking creating a composite score that takes into account frequency and severity of the symtoms. The score ranges from 0 to 120. Lower scores represent a better outcome.
Time frame: Baseline (Weeks 1-4) and Post-Treatment (Week 11)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS) | 1.23 score on scale | Standard Deviation 9.5 |
p-value: 0.55195% CI: [-2.9, 5.44]t-test, 2 sided
Secondary
Change From Pre-Test to Post-Test for the Knowledge Assessment for BRAIN Training for Staff
Staff took a quiz at pre-test and again at post-test. Scores range from 0 to 100, with higher scores representing a better outcome
Time frame: Baseline (Week 1) and Post-Training (Week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persons With Dementia | Change From Pre-Test to Post-Test for the Knowledge Assessment for BRAIN Training for Staff | 27.43 percent score on quiz out of 100 | Standard Deviation 0.11 |
p-value: <0.00195% CI: [17.7, 37.2]t-test, 2 sided
Secondary
Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia.
Staff were asked if they thought the BRAIN app would improve quality of life of persons with dementia.. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome.
Time frame: Post-Treatment (Week 11)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Persons With Dementia | Percent of Staff Who Said They Thought the BRAIN App Would Improve Quality of Life of Persons With Dementia. | 100 percentage who said yes |
Secondary
Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues
Staff were asked if they would recommend BRAIN Activities to colleagues. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome.
Time frame: Post-Treatment (Week 11)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Persons With Dementia | Percent of Staff Who Said They Would Recommend the BRAIN App to Colleagues | 100 percentage who said yes |
Secondary
Percent of Staff Who Thought Residents Enjoyed BRAIN Activities
Staff were asked if they thought residents enjoyed using the BRAIN Activities. The total who said YES was converted into a percentage. Total score ranges from 0 to 100, with higher scores representing a better outcome.
Time frame: Post-Treatment (Week 11)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Persons With Dementia | Percent of Staff Who Thought Residents Enjoyed BRAIN Activities | 100 percentage who said yes |